Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Pomalidomide after CAR T-cell therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma

Official title: A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory CD19+ B-Cell Leukemias and Lymphomas

Run by University of Michigan Rogel Cancer Center · NCT07532525 · Data updated 2026-11-12

This phase 1 study tests whether pomalidomide, given after CD19 CAR T-cell therapy, is safe and may help people whose CD19+ B-cell leukemia or lymphoma has come back or not responded.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment12 (estimated)
SponsorUniversity of Michigan Rogel Cancer Center
Academic / other
Drugs / interventionspembrolizumab, ruxolitinib, imatinib, dasatinib, CAR-T, CAR T, chemotherapy, radiation, chimeric antigen receptor
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedAugust 26, 2026
Main results expectedAugust 2027
Study endsAugust 2028
Registry record updatedOctober 15, 2026
Trial IDNCT07532525 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with relapsed or refractory CD19+ B-cell leukemia or lymphoma who have received a commercially approved CD19 CAR T-cell product and are 28–56 days post-infusion.

Probably not a fit

Patients who do not tolerate pomalidomide or do not show any sign of clinical benefit may not experience improvement and will be monitored for safety.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human-style phase 1 trial to assess safety and potential activity of pomalidomide following CD19 CAR T-cell treatment in adults with relapsed or refractory CD19+ B-cell leukemia or lymphoma. Participants must be 18 or older and 28–56 days post CAR T-cell infusion, with specific blood and organ function criteria. The study examines whether pomalidomide can enhance CAR T-cell persistence and cancer control, while monitoring adverse events and response signals. Enrollment is conducted at the University of Michigan Rogel Cancer Center.

Why it matters

Potential benefit: If successful, pomalidomide after CAR T therapy could improve cancer control and prolong remission for eligible patients.

How similar studies have gone: Prior studies with similar immune-modulating approaches have shown potential to enhance CAR T-cell activity, but this exact post-CAR T strategy is investigational.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R/R CD19+ Bcell leukemias and lymphomas.
* Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.
* \>= 18 years in age at time of enrollment
* Subject is able to swallow pills/tablets
* Karnofsky performance score of \>= 50%
* Absolute neutrophil count (ANC) \>= 750/mm\^3 (granulocyte colony stimulating factor allowed)
* Platelets \>= 50,000/mm\^3 (transfusion independent for \>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \[thrombopoietin (TPO) mimetics allowed\])
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) per institution
* Alanine aminotransferase (ALT \[serum glutamate pyruvate transaminase (SGPT)\]) =\< 3 x institutional ULN per institution
* Serum albumin \>= 2.0 g/dL
* Creatinine clearance (Cockcroft-Gault equation) \>= 30 mL/min/1.73 m\^2
* Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program
* Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide
* Co-Enrollment: Willingness to consent/ co-enroll on BMT long term follow up study, HUM00043287 (UMCC2001-0234)

Exclusion Criteria:

* Patients with known progressive or refractory disease.
* The following transplant or CAR T-related events are excluded:

  * Active grade \>= 2 acute or chronic graft versus host disease (GVHD)
  * Active cytokine release syndrome (CRS) grade \>= 2
  * Active immune effector cell associated neurotoxicity (ICANS) grade \>= 2
* Subject receiving \>= 0.25 mg/kg/day of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine.
* Patient who smokes cigarettes.
* Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS/ICANS is allowed within the prior 28 days
* Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment
* Stem cell transplant or rescue following most recent CD19CART therapy
* History of allergic reactions to pomalidomide or any of the excipients and any similar compounds
* Intercurrent illness or conditions:

  * Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed
  * Active grade \>= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded
  * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded
  * History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment
* Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug
* HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay

Where it's running

  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Jennifer E Agrusa, MD — University of Michigan Rogel Cancer Center
  • Study coordinator: Jennifer E Agrusa, MD
  • Email: jagrusa@med.umich.edu
  • Phone: 734-232-9335

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.